The QMS gap assessment and integration project demonstrated how systematic evaluation, scientific documentation practices, and targeted training can achieve compliance with PIC/S PE 009 and Annex 3 requirements for radiopharmaceutical sponsors and importers.
GMP licensing and ISO accreditation are critical milestones for therapeutic goods manufacturers, testing laboratories, and biotechnology companies. A readiness assessment using a structured scorecard is essential to evaluate the effectiveness of QMS, operational workflows, documentation, personnel competence, and facility readiness.
AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance.
Preparing for a GMP inspection requires a comprehensive, structured approach encompassing quality management systems, documentation, facilities, equipment, personnel, process control, and risk management.